The following data is part of a premarket notification filed by Sri Johani Sdn. Bhd. with the FDA for Powdered Latex Examination Gloves (protein Label Claim).
| Device ID | K993458 |
| 510k Number | K993458 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) |
| Classification | Latex Patient Examination Glove |
| Applicant | SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor, MY 43300 |
| Contact | Lim Lee Aik |
| Correspondent | Lim Lee Aik SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor, MY 43300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 1999-11-10 |